Assays

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Thermo Fisher Scientific introduces One Lambda HybriType HLA Plus Flex Typing kit

March 26, 2025

Thermo Fisher Scientific has introduced the One Lambda HybriType HLA Plus Typing Flex kit, an next generation sequencing (NGS) hybrid capture assay featuring a probe-based design...

MDX

Syndromic tests expand the medical laboratory’s growing stewardship role

Marti Juanola Falgarona, PhD

March 21, 2025

Assays

Revvity’s EUROIMMUN receives CE mark for novel measles antibody detection assay

LABline

March 5, 2025

Assays

Labcorp Plasma Complete now available clinically

LABline

Feb. 26, 2025

Assays

Hologic announces FDA clearance of Aptima SARS-CoV-2 assay

LABline

Feb. 19, 2025

Assays

Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units

LABline

Jan. 30, 2025

Assays

Roche receives FDA clearance with CLIA waiver for cobas liat molecular tests to aid in diagnosing sexually transmitted infections at the point of care

LABline

Jan. 24, 2025

FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health...

Assays

Product Focus- Assays/Controls

MLO Staff

Dec. 23, 2024

Extend the power of HPV testing BD Onclarity HPV Assay offers extended genotyping to identify high-risk HPV types beyond 16, 18, and 45 and is approved for self-collection in ...

Sponsored Content

Assays

Value of a Chromatogram in Hemoglobin A1C Testing

Nov. 13, 2024

As diabetes management evolves, the use of advanced testing technologies like ion-exchange high-performance liquid chromatography (HPLC) for A1C (or HbA1c) testing has become ...

PIQRAY® is a registered trademark of Novartis AG. VECTIBIX® is a registered trademark of Immunex Corporation. BRAFTOVI® is a registered trademark of Array BioPharma Inc. in the United States and various other countries. ERBITUX® is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. MEKINIST® is a registered trademark of Novartis AG Corporation Switzerland. KEYTRUDA® is a registered trademark of Merck. LENVIMA® (lenvatinib) is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

Assays

Caris Life Sciences receives FDA approval for MI Cancer Seek as a companion diagnostic (CDx) test

LABline

Nov. 8, 2024

MI Cancer Seek is the first and only simultaneous whole exome and whole transcriptome-based assay with CDx indications for adults and pediatric patients.

yourgene_cystic_fibrosis_base_assay_ivdr

Assays

Yourgene Health Cystic Fibrosis Base assay receives IVDR accreditation

LABline

Oct. 18, 2024

Offers clinicians and patients additional confidence in quality and accuracy of test for cystic fibrosis diagnosis.

Sponsored Content

Video

Accessible and Accurate Testing Solutions from Home to Lab by Sekisui Diagnostics

Sept. 20, 2024

Accessible and Accurate Testing Solutions from Home to Lab by Sekisui Diagnostics.Sponsored by:

Assays

QIAGEN expands QIAcuity digital PCR offering with over new 100 assays via GeneGlobe platform

LABline

Sept. 19, 2024

QIAGEN adds over 100 new validated QIAcuity digital PCR assays for cancer research, inherited genetic disorders, infectious disease surveillance, and other applications.

Sponsored Content

Video

CLSI’s Focused on Preparing Labs for Change

Sept. 11, 2024

Clinical and Laboratory Standards Institute (CLSI) CEO Barb Jones shares how the global nonprofit’s standards, training and educational offerings prepare labs to meet the...

Assays

VITROS syphilis assay now available on VITROS 3600 immunodiagnostic system, VITROS 5600 and VITROS XT 7600 integrated systems in the U.S.

LABline

Aug. 30, 2024

QuidelOrtho receives FDA 510(k) clearance for its VITROS syphilis assay.

Sponsored Content

Video

Flexible Syndromic Solutions for Respiratory Diagnostics 

Aug. 30, 2024

Michelle Tabb and Giulia Amicarelli of Diasorin discuss the current challenges for respiratory testing and how customizable syndromic testing is contributing to diagnostic stewardship...